SPECTRALIS

GUDID 04059237000549

Heidelberg Engineering GmbH

Spectral-domain optical coherence tomography system

• Primary Device ID: 04059237000549
• NIH Device Record Key: 7c0fdb5d-250f-4e47-b315-d8b3fdd5d13f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPECTRALIS
• Version Model Number: Software with HEYEX 2 V6.10-US
• Company DUNS: 329833875
• Company Name: Heidelberg Engineering GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059237000549 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173648

FDA Product Code

• MYC: Ophthalmoscope, Laser, Scanning

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-04
• Device Publish Date: 2019-01-03

On-Brand Devices [SPECTRALIS]

• 04059237000549: Software with HEYEX 2 V6.10-US
• 04059237000525: Software V6.10-US
• 04059237000501: SP-PWS-1001A
• 04059237000358: Product Famliy with HEYEX 2 SW V6.9b-US
• 04059237000341: Product Family SW V6.9.1-US
• 04059237000310: Product Family SW V6.8a-US
• 04059237000303: Product Family SW V6.8-US
• 04059237000297: SPEC-CAM-S2610
• 04059237000280: SPEC-CAM-S2600
• 04059237000259: Image Capture Module SW V1.2
• 04059237000211: HMO
• 04059237000150: UWF1
• 04059237000136: WFO2
• 04059237000112: VAO
• 04059237000105: Product Family SW V6.6
• 04059237000099: SPEC-CAM-S3610
• 04059237000082: SPEC-CAM-S1610
• 04059237000075: SPEC-TSP
• 04059237000068: SP-PWS-2001A
• 04059237000051: SP-PWS-2000A
• 04059237000044: SP-PWS-1000A
• 04059237000037: SPEC-CAM-S3600
• 04059237000020: SPEC-CAM-S2000
• 04059237000013: SPEC-CAM-S1600
• 04059237000594: Software with HEYEX 2 V6.12_US
• 04059237000570: Software 6.12_US
• 04059237000716: SP-PWS-2001A [>20000]
• 04059237000488: Software with HEYEX 2 V6.14_US
• 04059237000464: Software 6.13_US
• 04059237000839: Software with HEYEX 2 V7.0-US
• 04059237000815: Software V7.0-US
• 04059237000891: S2002
• 04059237000884: S1002
• 04059237001034: Software V.7.2-US with Heidelberg Eye Explorer
• 04059237001027: Software V.7.2-US
• 04059237000792: S2610 [SN>20000]
• 04059237000723: S3610 [SN>20000]